SOPs for Analytical Method Development V 2.0

This SOP describes a standardized procedure for developing and validating thermal degradation studies of active pharmaceutical ingredients (APIs) and drug products. It aims to identify degradation pathways under elevated temperature conditions and support the development of stability-indicating methods in compliance with ICH Q1A(R2).
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This SOP describes the procedure for conducting oxidative degradation studies on active pharmaceutical ingredients (APIs) and drug products to determine their susceptibility to oxidative stress. The method is essential for developing stability-indicating analytical procedures as per ICH Q1A(R2) and Q2(R2) guidelines.
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To define a standard procedure for evaluating the degradation of active pharmaceutical ingredients (APIs) and drug products under high humidity conditions. This stress testing supports the development of stability-indicating analytical methods and ensures the moisture sensitivity profile of pharmaceutical substances is well characterized.
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To define the procedure for the application of bracketing and matrixing approaches in the stability method development phase, aiming to reduce the number of stability samples tested without compromising scientific validity, in accordance with ICH Q1D guidelines.
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To define the procedure for developing and validating analytical methods intended to determine the shelf-life of pharmaceutical products. These methods shall demonstrate stability-indicating capabilities to detect changes in potency, degradation products, and overall quality over time.
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To outline a standardized procedure for demonstrating the stability-indicating capability of an analytical method through systematic forced degradation studies, peak purity analysis, and specificity evaluation in compliance with ICH Q1A(R2) and Q2(R2).
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This SOP defines a standard procedure for the identification and characterization of unknown degradation products that appear during forced degradation, stability, or shelf-life studies using advanced instrumental techniques such as LC-MS/MS, PDA, FTIR, and NMR.
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To define the procedure for planning analytical method validation activities within the Analytical Method Development (AMD) department, ensuring compliance with ICH Q2(R2) guidelines and internal quality requirements.
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To define the procedure for conducting specificity testing as part of analytical method validation to demonstrate the method’s ability to unequivocally assess the analyte in the presence of other expected components such as impurities, degradants, and excipients.
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To define a systematic procedure for evaluating the accuracy of analytical methods through recovery studies, where known quantities of analyte are added to the sample matrix and quantified using the proposed method to validate its accuracy.
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